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Poonawalla said the UK government will share the data on the efficacy of the vaccine in the next two to three weeks. If it says the vaccine is safe, SII will apply for the emergency use authorisation at the Drug Controller General of India (DCGI) for the vaccine in December.
"We're basing the assumption on emergency licensure based on the positive UK results. So these are the caveats. If we get a good UK result by the end of November or early December, we can apply for an emergency licensure use".
Poonawalla said if things go according to the plan, the coronavirus vaccine will be available for vulnerable populations by January or February. And, in March or April, the vaccine will enter the market for the general public.
However, if it gets delayed, Serum's own plans will go behind schedule, Poonawallla said.
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SII, which is the world's largest vaccine maker by volume, is trying to expand its capacity for manufacturing the vaccine to around 10 crore doses from around 5-6 crore doses now.
So far, Serum Insititute has signed a bilateral pact for vaccine supply with Bangladesh. And, the Pune-based institute is not planning to sign a pact with other countries because it may not be able to provide vaccines. According to Poonawalla, India's billion-plus population will be Serum's primary concern.
Also read: Serum Institute to roll out COVID-19 vaccine in India by January 2021: Adar Poonawalla
Serum Institute is currently conducting the phase-3 trial of Oxford-AstraZeneca's COVID-19 vaccine candidate in India. It is anticipated that Covishield will be one of the first to secure regulatory approval, along with vaccine candidates from US-based Pfizer and Moderna Inc, as scientists across the world try to find a vaccine against novel coronavirus.
Serum Institute has also signed pacts with the Bill and Melinda Gates Foundation and Gavi, the Vaccine Alliance, for the manufacturing and delivery of as many as 20 crore doses of COVID-19 vaccines from Oxford and Novavax.
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